OPtimized Stenting Using Intravascular Ultrasound(IVUS) in Long lEsion: Rationale for Simplified criteriA (OPERA)

Centre Chirurgical Marie Lannelongue

Status: Completed

Conditions: Restenosis; Diabetes; Coronary Heart Disease; Chronic Total Occlusion of Coronary Artery; Vascular Lesions

Treatments: Device: TAXUS™ Element long stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01861860

P12-37811002 / 2012-A00696-37

Details and patient eligibility

About

Rationale IVUS has shown to be efficient for bare metal stent deployment, but has not been specifically studied for Drug Eluting Stents. The angiographically versus IVUS optimization (AVIO) study was performed with (medical device's type )Promus stent, results are promising, but the study was not designed for clinical endpoint.

There is no consensus on IVUS criteria for stent deployment. The MUSIC criteria were widely used in the early 2000, but have limitations for complex long lesions. The AVIO criteria were recently proposed for complex lesions, but these criteria also have some issues and the complexity make their routine use challenging.

We performed a pilot study for long complex lesion analysis using IVUS, in order to define easy to use criteria, applicable for complex lesions in drug eluting stents (DES) era. The new criteria (OPERA) are an adaptation of the MUSIC criteria.

OTELLO study is an ongoing trial sponsored by Boston Scientific Inc, to determine Major Adverse Cardiac Event with the new TAXUS Element stent. 500 patients will be enrolled in the study.

Main question Is IVUS using simplified new criteria beneficial for long (>28mm) TAXUS element stent deployment?

Study design This study will consist to prospectively include consecutive patients with>28mm taxus element stent using IVUS. OPERA Criteria for stent deployment will be the objectives to reach. OPERA is an adaptation of the MUSIC criteria for long complex lesion. The patients from the OTELLO study, with the same inclusion criteria, will composed the control group . Population will be matched using the propensity score.

20 to 30 French centers involved in OTELLO study will be contacted for participating in OPERA.

Hypothesis:

Long lesion percutaneous coronary intervention(PCI) have specific characteristics like Diffuse old atheroma Calcifications Discrepancies between prox and distal diameter Infiltration longer than the target lesion Bifurcations Inhomogeneous strength due to the balloon (Laplace law) Primary hypothesis Long Taxus element deployed using IVUS and OPERA criteria have better outcomes than without IVUS

Primary Objectives 38% MACE (SAT, target lesion revascularization (TLR), myocardial infarction (MI), Death) reduction using IVUS and OPERA criteria for Taxus element ≥ 28 mm implantation

Secondary endpoint

1. MACE determination for Taxus element ≥ 28 mm implantation with IVUS and OPERA criteria
2. Safety: procedural Stroke, Urgent cardiac surgery, procedural MI
3. Comparison of IVUS criteria: OPERA, MUSIC, AVIO

Secondary objectives Safety of OPERA criteria Feasibility of using OPERA criteria in non expert IVUS center MACE determination with a 4% margin error for Taxus element ≥ 28 mm implantation with IVUS and OPERA criteria

Methods Inclusion of consecutive patients using IVUS Taxus element ≥ 28 mm in a multicentric study propensity score matched analysis matched for comparison to OTELLO study. (Same inclusion criteria as OTELLO)

Statistical analysis Primary Endpoint: MACE expected in the OTELLO study=18% MACE expected in the OPERA study=11% Number of patient in the OTELLO study=500 Alpha=0.05,1- Beta=0.73 Number of patients analysable in the OPERA study needed =250 patients i.e 300 pts inclusions.

Secondary Endpoint 4% margin error with a MACE of 11% need also 250 pts

Type of study Biomedical research French study Centralized IVUS analysis 1, 6 and 12 months telephone contact

Safety and efficacy measures Efficacy: MACE (Cardiac Death, target vessel revascularization (TVR), Myocardial Infarction) at 12 months Safety: procedure related event: Urgent surgery, According to Good Clinical Practices serious adverse event (SAE) declared within 24 Hours

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years
• Patients who have had a coronary angioplasty with implantation of a TAXUS™ Element™ stent of 28, 32 and 38 mm in length and up to 3 stents per patient in the case of acute occlusive dissection deployed using IVUS
• Patients with indication of Taxus™ Element™ stent included in the List of Reimbursable Products and Supplies (LPPR):
• diabetes,
• small vessel (less than 3 mm in diameter),
• long lesion(s) (more than 15 mm long),
• chronic total occlusion > 1 month,
• intra-stent restenosis with the exclusion drug eluting stent(s), restenosis of
• people with a lesion that is accessible to IVUS after stenting
• people who have provided consent for collection of medical data for this trial.

Exclusion criteria

-Those who refuse to consent to the collection and/or processing of data necessary to complete the trial and/or the centralized follow-up

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

New OPERA Criteria

Experimental group

Description:

TAXUS™ Element long stent

Treatment:

Device: TAXUS™ Element long stent